BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 15723613 · Received November 3, 2022

    Report

    Report Number
    3020584246-2022-00060
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 3, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEM, LLC
    Product Code
    HWC
    UDI-DI
    00815432029587
    PMA / PMN Number
    K193452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER STATES THAT THE ANTI-DRIFT BOLT WAS REMOVED BY THE SURGEON APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE. NO PAIN OR SYMPTOMS WERE REPORTED WITH THE SCREW MIGRATION. THE JOINT WAS FUSED. THE ANTI-DRIFT BOLT WAS REMOVED, AND THE PATIENT RETURNED TO FULL ACTIVITY. NON-CONFORMANCE WAS NOT IDENTIFIED BASED ON THE LOTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THE ROOT CAUSE IS UNKNOWN. POTENTIALLY, FORCE FROM WEIGHT-BEARING WITH NORMAL WALKING MOTION CAUSED THE SCREW TO BACK-OUT. SCREW BACK-OUT IS A KNOWN FAILURE MODE OF SCREWS. THE FOLLOWING IMPLANT WERE ALSO INCLUDED IN THE CONTRUCT. ONLY THE ANTI-DRFIT BOLT WAS REMOVED. REF: 7100-LP18-L LN: 501730 QTY: 1 PRODUCT NAME: DYNABUNION PLATE 18MM-LEFT PACK-OUT. REF: 7118-1818KT-C LN: 300281 QTY: 1 PRODUCT NAME: DYNAFORCE HIMAXC IMPLANT KIT 18X18X18. REF: 15PL-3516 LN: 400353 QTY: 1 PRODUCT NAME: MOTOBAND CP POLYAXIAL LOCKING SCREW 3.5MM X 16 MM STERILE. REF: 1500-3522 LN: 400151 QTY: 1 PRODUCT NAME: MOTOBAND CP NON-LOCKING SCREW 3.5MM X 22MM STERILE. REF: 1500-3516 LN: 400342 QTY: 1 PRODUCT NAME: MOTOBAND CP NON-LOCKING SCREW 3.5MM X 16MM STERILE.

    Description of Event or Problem · 0

    THE REPORTER STATES THAT THE ANTI-DRIFT BOLT WAS REMOVED BY THE SURGEON APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE. NO PAIN OR SYMPTOMS WERE REPORTED WITH THE SCREW MIGRATION. THE JOINT WAS FUSED. THE ANTI-DRIFT BOLT WAS REMOVED, AND THE PATIENT RETURNED TO FULL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496357 MOTOBAND CP IMPLANT SYSTEM SCREW HWC CROSSROADS EXTREMITY SYSTEM, LLC Implant, 3.5mm x 38mm Anti-Drift Bolt, Fully Threaded 400316 00815432029587

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other